(206 days)
The SteriTec Instant Readout Chemical Integrator Chailenge Pack is a steam sterilization process challenge device that meets the FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs. The Integrator Challenge Pack monitors pre-vacuum steam sterilizers operating at 132°C (270°F) or 135°C (275°F). When exposed to steam sterilization conditions the Instant Readout Chemical Integrator card gives an integrated response by changing from purple to green. The integrator card inside the test pack also meets emulator performance standards according to ISO 11140-1:2005.
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The provided text is related to a 510(k) premarket notification for a medical device called "SteriTec Instant Readout Chemical Integrator Challenge Pack, Model No.: I.T 105". This document is an FDA clearance letter and an "Indications for Use" statement. It does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and a study proving device performance in the context of advanced AI/ML algorithms.
Specifically, the document refers to a chemical indicator and its performance requirements according to FDA Chemical Indicator Guidelines and ISO 11140-1:2005. The "performance" in this context refers to the chemical integrator changing color to indicate successful sterilization conditions, not the performance of an AI/ML algorithm.
Therefore, many of your requested points are not applicable or cannot be extracted from this document, as they relate to AI/ML device studies.
However, I can extract the following information based on the document:
Acceptance Criteria and Reported Device Performance (as a chemical integrator)
The device is a chemical integrator, and its performance is described in terms of its response to specific steam sterilization conditions. The "Indications for Use" statement outlines the critical parameters and the expected response.
| Acceptance Criteria (from FDA Chemical Indicator Guidelines & ISO 11140-1:2005 performance requirements for chemical integrator test packs) | Reported Device Performance (from the document) |
|---|---|
| General Performance: Meets FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs. Monitors pre-vacuum steam sterilizers. Meets emulator performance standards according to ISO 11140-1:2005. |
Specific Performance (Critical Parameters in hospital steam sterilizers - likely referring to minimum exposure times required to achieve "pass" indication for different thresholds, or absence of "pass" for under-exposure):
| General Performance: The SteriTec Instant Readout Chemical Integrator Challenge Pack "meets the FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs." The Integrator Challenge Pack "monitors pre-vacuum steam sterilizers operating at 132°C (270°F) or 135°C (275°F)." "When exposed to steam sterilization conditions the Instant Readout Chemical Integrator card gives an integrated response by changing from purple to green." "The integrator card inside the test pack also meets emulator performance standards according to ISO 11140-1:2005."
Specific Performance Thresholds (as described for the device): The table in the "Indications for Use" provides the "Critical Parameters" for the device, which, in the context of a chemical integrator, define the conditions under which it is expected to respond. The "Indicator "A", "B", "C"" columns likely correspond to different performance thresholds within the ISO standard or internal validation, showing the minimum exposure times at which the integrator should indicate a "pass" or "fail" for various conditions. For a chemical integrator, "performance" means accurately reflecting the conditions it is designed to monitor (e.g., changing color when sterilization conditions are met, and not changing color when they are not). The document implies the device operates according to these thresholds.
132°C (270°F) / Pre-Vacuum:
- Indicator "A": 4 minutes
- Indicator "B": 10 minutes
- Indicator "C": 20 minutes
135°C (275°F) / Pre-Vacuum:
- Indicator "A": 3 minutes
- Indicator "B": 8 minutes
- Indicator "C": 16 minutes
(Note: The document doesn't explicitly state "pass/fail" results for these specific indicator times, but rather lists them as the "Critical Parameters" the device monitors and for which its performance is defined against, i.e., it must behave as expected at these time points for each indicator type.) |
| Temperature/Sterilizer Type:
- 132°C (270°F) / Pre-Vacuum
- 135°C (275°F) / Pre-Vacuum | |
Study Proving Device Meets Acceptance Criteria:
The document explicitly states: "The SteriTec Instant Readout Chemical Integrator Challenge Pack is a steam sterilization process challenge device that meets the FDA Chemical Indicator Guidelines performance requirements for chemical integrator test packs." And, "The integrator card inside the test pack also meets emulator performance standards according to ISO 11140-1:2005."
This indicates that the device underwent testing to demonstrate compliance with these established standards. However, the document does not provide the details of this study, such as its methodology, results, or specific data.
Information NOT available in the provided document (as it pertains to AI/ML studies and not applicable to this chemical indicator device):
- Sample size used for the test set and the data provenance: Not applicable. This refers to a physical chemical indicator, not an algorithm processing data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a chemical indicator is determined by physical sterilization conditions and its visual color change.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This device doesn't involve human readers or AI assistance in a diagnostic context.
- Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a chemical indicator, the ground truth is the actual physical parameters of the sterilization cycle (temperature, time, steam quality), verified by calibrated equipment. The "expert consensus" relates to the FDA and ISO standards defining what constitutes a successful sterilization cycle and thus a "pass" indication from the device.
- The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires training data.
- How the ground truth for the training set was established: Not applicable.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).